Description

Betrixaban Impurity 2 is a specified impurity of the anticoagulant active pharmaceutical ingredient (API) Betrixaban. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Betrixaban drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Betrixaban API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure compliance with pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities in new drug substances.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Betrixaban to minimize the formation of this impurity.

Basic Information

Product Name	Betrixaban Impurity 2
CAS No.	330942-04-6
Molecular Formula	C23H22ClN5O3
Molecular Weight	451.91 g/mol
Synonyms	N-(5-Chloro-2-pyridinyl)-N'-[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methyl]urea; Betrixaban Related Compound B; Betrixaban EP Impurity B; Betrixaban USP Impurity; Betrixaban Process Impurity; 1-((5S)-2-Oxo-3-(4-(3-oxomorpholino)phenyl)oxazolidin-5-yl)methyl)-3-(5-chloropyridin-2-yl)urea
EINECS	Contact for details

Quality Control

Our Betrixaban Impurity 2 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analysis. We adhere to relevant guidelines for reference standards, ensuring data integrity and traceability for pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.